Computer-Implemented Infrastructure, Methods, Systems, and Computer-Readable Media For Generating and Managing Product Labels For a Product Across a Plurality of Jurisdictions

ABSTRACT

A system for generating product label changes is described. The system includes a product labeling platform executable on a network enabled computing device and a database of at least one selectable master label and at least one selectable jurisdiction label associated with a labeled product. The platform associates at least one selected descriptor from a first pre-defined descriptor set to each change made to a selected master label, and further associates at least one selected descriptor from a second pre-defined descriptor set to each change made to a selected jurisdiction label. The platform further associates a report including the selected descriptors from the first and second pre-defined descriptor sets with the changed label. A system for generating and managing product labels for a product across multiple jurisdictions is also disclosed. Methods including a computer-implemented method of updating a product label and a computer-implemented method of generating and managing product labels for a product across a plurality of jurisdictions are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a '371 National Stage Entry of PCT/US17/41864, filedJul. 13, 2017, which claims priority to U.S. Provisional Application No.62/361,874, filed on Jul. 13, 2016, and U.S. Provisional Application No.62/393,663, filed on Sep. 13, 2016, all of which are incorporated hereinby reference in their entireties.

BACKGROUND OF THE INVENTION

Regulated products such as pharmaceuticals are subject to varying legaland regulatory frameworks across a plurality of jurisdictions. Althoughthe underlying product almost always contains the same activepharmaceutical ingredient across jurisdictions, and product labelsusually contain at least some language in common across jurisdictions,the particular text of the label is subject to approval by individualregulatory authorities and often divergent requirements. Conventionalword processing, spreadsheet, and/or document management systems haveproved ineffective in managing such labels across a plurality ofjurisdictions.

SUMMARY OF THE INVENTION

In one embodiment, a computer-implemented method of updating a productlabel, includes the steps of selecting a master label or jurisdictionproduct label associated with a labeled product, entering at least onechange to information contained in a section of the master label orjurisdiction product label, qualifying the at least one informationchange via selection of at least one descriptor from a first pre-defineddescriptor set, selecting a label for the labeled product, entering atleast one change to information contained in the label that iscommensurate with the information change in the master label orjurisdiction product label, qualifying the at least one informationchange in the label via selection of at least one descriptor from asecond pre-defined descriptor set, and generating a report of the atleast one label change including the changed label and a summaryincluding the selected descriptors from the first and second pre-defineddescriptor sets. In one embodiment, the first descriptor set includespre-defined selectable options from at least one category from the groupconsisting of Change Rationale, Safety Change, and Change Type. In oneembodiment, the pre-defined selectable options under the Change Typecategory include an urgency level. In one embodiment, the pre-definedselectable options under the Change Type category include anidentification of mandatory, optional or administrative. In oneembodiment, the second descriptor set includes pre-defined selectableoptions pertaining to the alignment of the information change in thelabel to the information change in the company core data sheet. In oneembodiment, the pre-defined selectable options are from the groupconsisting of Major Deviation, Minor Deviation, and Aligned.

In one embodiment, a system for generating product label changesincludes a product labeling platform executable on a network enabledcomputing device, and a database of at least one selectable master labeland at least one selectable jurisdiction label associated with a labeledproduct, where the platform associates at least one selected descriptorfrom a first pre-defined descriptor set to each change made to aselected master label, and further associates at least one selecteddescriptor from a second pre-defined descriptor set to each change madeto a selected jurisdiction label, and where the platform furtherassociates a report including the selected descriptors from the firstand second pre-defined descriptor sets with the changed label. In oneembodiment, the first descriptor set includes pre-defined selectableoptions from at least one category from the group consisting of ChangeRationale, Safety Change, and Change Type. In one embodiment, thepre-defined selectable options under the Change Type category include anurgency level. In one embodiment, the pre-defined selectable optionsunder the Change Type category include an identification of mandatory,optional or administrative. In one embodiment, the second descriptor setincludes pre-defined selectable options pertaining to the alignment ofthe information change in the label to the information change in thecompany core data sheet. In one embodiment, the pre-defined selectableoptions are from the group consisting of Major Deviation, MinorDeviation, and Aligned.

In one embodiment, a computer-implemented method of generating andmanaging product labels for a product across multiple jurisdictions, thecomputer-implemented method includes the steps of generating a masterlabel for the product by presenting a first graphical user interfaceincluding multiple master template headers defined by a master template,and corresponding master label fields for input of master label contentassociated with the master template headers, receiving master labelinput to the corresponding master label fields via the first graphicaluser interface, and storing the master label content input in a masterlabel data structure, and upon receiving a request to generate ajurisdiction-specific product label for the product for the particularjurisdiction, presenting a second graphical user interface including:multiple master template headers defined by the master template,corresponding master label content stored in the master label datastructure, multiple jurisdiction template headers defined by ajurisdiction template, and corresponding jurisdiction-specific productlabel fields for input of jurisdiction-specific product label contentassociated with the jurisdiction-specific product label headers,allowing a user to select and modify portions of the master labelcontent to populate the jurisdiction-specific product label fields,receiving jurisdiction-specific product label input to the correspondingjurisdiction-specific product label fields via the second graphical userinterface, and storing the jurisdiction-specific product label input ina jurisdiction-specific product label data structure. In one embodiment,the master label data structure includes references to master templateheaders from the master label data structure, and modified master labelheaders. In one embodiment, the jurisdiction-specific product label datastructure includes references to jurisdiction template headers from thejurisdiction template, modified jurisdiction label headers, referencesto unmodified label elements from the master label data structure, andmodified label elements relative to the master label data structure. Inone embodiment, at least one of the master label data structure and thejurisdiction-specific product label data structure includes metadata orreferences to metadata selected from the group consisting of: supportingdocuments, change tracking data, labeling code, establishmentinformation, drug listing, and workflow data. In one embodiment, themaster label data structure and the jurisdiction-specific product labeldata structure are implemented in a database. In one embodiment, thedatabase is a relational database. In one embodiment, the master labeldata structure and the jurisdiction-specific product label datastructure contain references to a database. In one embodiment, thecomputer-implemented method includes presenting the master label or thejurisdiction-specific product label to one or more users for review, QC,or approval based on a workflow specified in computer-readable media. Inone embodiment, the computer-implemented method includes tracking thereview, QC, or approval of the master label or the jurisdiction-specificproduct label in computer-readable media. In one embodiment, thecomputer-implemented method includes generating a report detailing thetracked review, QC, and approval of the master label or thejurisdiction-specific product label. In one embodiment, the secondgraphical user interface displays the master label and thejurisdiction-specific product label side-by-side. In one embodiment, thesecond graphical user interface is further configured to synchronizepositioning of the master label and the jurisdiction-specific productlabel such that corresponding sections of the master label and thejurisdiction-specific product label are substantially verticallyaligned. In one embodiment, the corresponding sections are identifiedindependent of text contained therein. In one embodiment, thecomputer-implemented method includes receiving a request to change aportion of at least one of the master label and thejurisdiction-specific product label, and prompting the user to qualifythe requested change by selecting at least one descriptor from apre-defined descriptor set including one or more selected from the groupconsisting of: a change rationale, a safety change, a change type,alignment to a source label, and label deadlines. In one embodiment, thecomputer-implemented method includes tracking the requested changes, andgenerating a report of changes, the report including the at least onedescriptor selected from the pre-defined descriptor set, a status of ananticipated change to a label, a status of a changed label, and asummary of the changes. In one embodiment, the change rationale metadatarequires identification of a reason for the change. In one embodiment,the reason for the change can include one or more selected from thegroup consisting of: “new data”, “health authority request”, and “updateto source label”. In one embodiment, the “change type” metadata requiresidentification of the change selected from the group consisting of:“urgent”, “non-urgent”, “mandatory”, “optional”, and “administrative”.In one embodiment, the “alignment to source label” metadata requiresidentification of a degree of the change in relationship to a sourcelabel and selected from the group consisting of: “major deviation”,“minor deviation”, and “aligned”. In one embodiment, the “labeldeadlines” metadata requires identification of a deadline forimplementation of the change. In one embodiment, the “label deadlines”metadata further comprises identification of compliance to theidentified deadline for implementation of the change. In one embodiment,the identification of compliance is selected from the group consistingof: “compliant”, “not applicable”, and “delegated”. In one embodiment,the at least one descriptor is implemented in the database and isassociated with the respective master label data structure orjurisdiction-specific product label data structure as implemented in thedatabase.

In one embodiment, a system for generating and managing product labelsfor a product across multiple jurisdictions includes a computerincluding a storage device including a database management system, and acomputer-readable program code including steps for generating a masterlabel for the product by presenting a first graphical user interfaceincluding multiple master template headers defined by a master templatestored, at least in part, in the database management system, andcorresponding master label fields for input of master label contentassociated with the master template headers, receiving master labelinput to the corresponding master label fields via the first graphicaluser interface, and storing the master label content input in a masterlabel data structure at least in part in the database management system,and upon receiving a request to generate a jurisdiction-specific productlabel for the product for the particular jurisdiction, presenting asecond graphical user interface including the multiple master templateheaders defined by the master template and stored, at least in part, inthe database management system, corresponding master label contentstored in the master label data structure stored, at least in part, inthe database management system, multiple jurisdiction template headersdefined by a jurisdiction template stored, at least in part, in thedatabase management system, and corresponding jurisdiction-specificproduct label fields for input of jurisdiction-specific product labelcontent associated with the jurisdiction-specific product label headers,allowing a user to select and modify portions of the master labelcontent to populate the jurisdiction-specific product label fields,receiving jurisdiction-specific product label input to the correspondingjurisdiction-specific product label fields via the second graphical userinterface, and storing the jurisdiction-specific product label input ina jurisdiction-specific product label data structure at least in part inthe database management system. In one embodiment, the computer is anetworked computer. In one embodiment, the master label data structureincludes references to master template headers from the master labeldata structure, and modified master label headers. In one embodiment,the jurisdiction-specific product label data structure includesreferences to jurisdiction template headers from the jurisdictiontemplate, modified jurisdiction label headers, references to unmodifiedlabel elements from the master label data structure, and modified labelelements relative to the master label data structure. In one embodiment,at least one of the master label data structure and thejurisdiction-specific product label data structure includes metadata orreferences to metadata selected from the group consisting of: supportingdocuments, change tracking data, labeling code, establishmentinformation, drug listing, and workflow data. In one embodiment, themaster label data structure and the jurisdiction-specific product labeldata structure are implemented in a database. In one embodiment, thedatabase is a relational database. In one embodiment, the master labeldata structure and the jurisdiction-specific product label datastructure contain references to a database. In one embodiment, thecomputer-readable program code further includes steps for presenting themaster label or the jurisdiction-specific product label to one or moreusers for review, QC, or approval based on a workflow specified incomputer-readable media. In one embodiment, the computer-readableprogram code further includes steps for tracking the review, QC, orapproval of the master label or the jurisdiction-specific product labelin computer-readable media. In one embodiment, the computer-readableprogram code further includes steps for generating a report detailingthe tracked review, QC, and approval of the master label or thejurisdiction-specific product label. In one embodiment, the secondgraphical user interface displays the master label and thejurisdiction-specific product label side-by-side. In one embodiment, thesecond graphical user interface is further configured to synchronizepositioning of the master label and the jurisdiction-specific productlabel such that corresponding sections of the master label and thejurisdiction-specific product label are substantially verticallyaligned. In one embodiment, the corresponding sections are identifiedindependent of text contained therein. In one embodiment, thecomputer-readable program code further includes steps for receiving arequest to change a portion of at least one of the master label and thejurisdiction-specific product label, and prompting the user to qualifythe requested change by selecting at least one descriptor from apre-defined descriptor set including one or more selected from the groupconsisting of: a change rationale, a safety change, a change type,alignment to a source label, and label deadlines. In one embodiment, thecomputer-readable program code further includes steps for tracking therequested changes, and generating a report of changes, the reportincluding the at least one descriptor selected from the pre-defineddescriptor set, a status of an anticipated change to a label, a statusof a changed label, and a summary of the changes. In one embodiment, thechange rationale metadata requires identification of a reason for thechange. In one embodiment, the reason for the change can include one ormore selected from the group consisting of: “new data”, “healthauthority request”, and “update to source label”. In one embodiment, the“change type” metadata requires identification of the change selectedfrom the group consisting of: “urgent”, “non-urgent”, “mandatory”,“optional”, and “administrative”. In one embodiment, the “alignment tosource label” metadata requires identification of a degree of the changein relationship to a source label and selected from the group consistingof: “major deviation”, “minor deviation”, and “aligned”. In oneembodiment, the “label deadlines” metadata requires identification of adeadline for implementation of the change. In one embodiment, the “labeldeadlines” metadata further comprises identification of compliance tothe identified deadline for implementation of the change. In oneembodiment, the identification of compliance is selected from the groupconsisting of: “compliant”, “not applicable”, and “delegated”. In oneembodiment, the at least one descriptor is implemented in the databaseand is associated with the respective master label data structure orjurisdiction-specific product label data structure as implemented in thedatabase.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature and desired objects of thepresent invention, reference is made to the following detaileddescription taken in conjunction with the accompanying drawing figureswherein like reference characters denote corresponding parts throughoutthe several views.

FIG. 1 depicts an exemplary network topology according to an embodimentof the invention.

FIG. 2 depicts an exemplary framework for storing data according to anembodiment of the invention.

FIG. 3 depicts a method for creating and/or managing a product labelaccording to an embodiment of the invention.

FIGS. 4A-4T depict various user interfaces according to an embodiment ofthe invention.

FIG. 5 depicts a method of managing an update to a product labelaccording to an embodiment of the invention.

FIG. 6 depicts a computer-implemented method of updating a product labelaccording to an embodiment of the invention.

DEFINITIONS

The instant invention is most clearly understood with reference to thefollowing definitions.

As used herein, the singular form “a,” “an,” and “the” include pluralreferences unless the context clearly dictates otherwise.

Unless specifically stated or obvious from context, as used herein, theterm “about” is understood as within a range of normal tolerance in theart, for example within 2 standard deviations of the mean. “About” canbe understood as within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%,0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise clear fromcontext, all numerical values provided herein are modified by the termabout.

As used in the specification and claims, the terms “comprises,”“comprising,” “containing,” “having,” and the like can have the meaningascribed to them in U.S. patent law and can mean “includes,”“including,” and the like.

As used to herein, the term “computer-readable medium” broadly refers toand is not limited to a register, a cache memory, a ROM, a semiconductormemory device (such as a D-RAM, S-RAM, or other RAM), a magnetic mediumsuch as a flash memory, a hard disk, a magneto-optical medium, anoptical medium such as a CD-ROM, a DVD, or BD, or other type of devicefor electronic data storage.

As used in the specification and claims, the term “jurisdiction” refersto a “geographic area within which political or judicial authority maybe exercised” and/or a “political or judicial subdivision within such anarea”. Black's Law Dictionary 855 (7th ed. 1999) (Bryan A. Garner ed.).Examples of jurisdictions include supranational (e.g.,politico-economic) unions such as the European Union, sovereign statessuch as Germany or the United States of America, and politicalsubdivisions thereof such as the Commonwealth of Pennsylvania or theCity of Philadelphia.

Unless specifically stated or obvious from context, the term “or,” asused herein, is understood to be inclusive.

As used herein, the term “processor” broadly refers to and is notlimited to a single- or multi-core processor, a special-purposeprocessor, a conventional processor, a Graphics Processing Unit (GPU), adigital signal processor (DSP), a plurality of microprocessors, one ormore microprocessors in association with a DSP core, a controller, amicrocontroller, one or more Application Specific Integrated Circuits(ASICs), one or more Field Programmable Gate Array (FPGA) circuits, anyother type of integrated circuit (IC), a system-on-a-chip (SOC), and/ora state machine.

In some aspects of the present invention, software executing theinstructions provided herein may be stored on a non-transitorycomputer-readable medium, wherein the software performs some or all ofthe steps of the present invention when executed on a processor.

Aspects of the invention relate to algorithms executed in computersoftware. Though certain embodiments may be described as written inparticular programming languages, or executed on particular operatingsystems or computing platforms, it is understood that the system andmethod of the present invention is not limited to any particularcomputing language, platform, or combination thereof. Software executingthe algorithms described herein may be written in any programminglanguage known in the art, compiled or interpreted, including but notlimited to C, C++, C #, Objective-C, Java, JavaScript, Python, PHP,Perl, Ruby, or Visual Basic. It is further understood that elements ofthe present invention may be executed on any acceptable computingplatform, including but not limited to a server, a cloud instance, aworkstation, a thin client, a mobile device, an embeddedmicrocontroller, a television, or any other suitable computing deviceknown in the art.

Ranges provided herein are understood to be shorthand for all of thevalues within the range. For example, a range of 1 to 50 is understoodto include any number, combination of numbers, or sub-range from thegroup consisting 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34,35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 (aswell as fractions thereof unless the context clearly dictatesotherwise).

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the invention provide computer-implemented methods,computer-readable media, and systems for generating and managing productlabels for one or more products across a plurality of jurisdictions.

Embodiments of the invention are particularly useful for regulatedproducts such as pharmaceuticals that are subject to varying legal andregulatory frameworks across a plurality of jurisdictions. For example,embodiments of the invention provide and implement documented andcontrolled methods for processes that exceed the capabilities ofexisting multiple word processing and spreadsheet applications.

Exemplary Network Topology

Referring to FIG. 1 , an exemplary network topology 100 for anembodiment of the invention described herein is depicted. Embodiments ofthe invention can be implemented on server 102, which is incommunication with clients 104 a-c via network 106.

The terms “client” and “server” are used to reflect a client-serverrelationship between elements 102 and 104 a-104 c. Suitable devices forserver element 102 include, but are not limited to general-purposecomputers including, but not limited to, computers and/or devices withhigher processing power colloquially known as “servers.” Likewise,suitable devices for client elements 104 a-104 c include, but are notlimited to general purpose computers, including, but not limited todesktop computers, laptop computers, tablet computers, personal digitalassistants, cellular telephones, smartphones, and the like.

Network 106 can be any network capable of transmitting data betweenclients 104 a-104 c and server 102, for example, an intranet or theInternet.

The server 102 can be in communication with a database 108. Database 108can be operated through a database management system (DBMS). A DBMS isimposed upon the data to form a logical and structured organization ofthe data. A DBMS lies between the physical storage of data and theusers, and handles the interaction between the two. Examples of DBMSesinclude DB2® and INFORMIX®, both available from IBM Corp. of Armonk,N.Y.; MICROSOFT EXCEL®, MICROSOFT JET®, and MICROSOFT SQL SERVER®, allavailable from the Microsoft Corp. of Redmond, Wash.; MYSQL®, availablefrom the MySQL Ltd. Co. of Stockholm, Sweden; ORACLE® Database,available from Oracle Intl Corp. of Redwood City, California; andSYBASE®, available from Sybase, Inc. of Dublin, California.

Depending on the particular implementation, server 102 and/or clients104 a-c can be programmed to generate and/or display one or moregraphical user interfaces that allow users to interact with the server104 through graphical icons and visual indicators. For example, server102 and/or clients 104 a-c can include charts or graphs (e.g., piecharts, bar charts, line charts, and the like) that can be generatedon-the-fly using custom widgets or commercially-available widgets suchas the GOOGLE® CHART API available from Google Inc. of Mountain View,California, the CorePlot, iOSPlot, iOS:Chart, KeepEdge Library, andShinobi Controls graphing libraries for the IOS® operating system fromApple Inc. of Cupertino, California, and the GraphView and AndroidPlotlibraries for the ANDROID™ operating system from Google Inc. of MountainView, California.

Although an exemplary network topology is described and depicted,embodiments of the invention can be implemented in a variety oftopologies. For example, embodiments of the invention can be implementedas a “cloud” or “as a service” model in which a company purchases asubscription and accesses a service through the Internet (which may runon servers 102 in a variety of locations such as the AMAZON EC2® elasticrepository service). In another embodiment, a company can license andhost an embodiment of an invention on a server 102 owned by the company.

Exemplary Data Storage Framework

Referring now to FIG. 2 , embodiments of the invention can structure,link, connect, and store data in a variety of formats. One exemplaryapproach is depicted.

A particular product label can be generated and/or represented throughthe combination of a plurality of templates: master label template 202and jurisdiction templates 204, 206. Master label template 202 canprovide a starting point for a particular master label 208 andjurisdiction templates 204, 206 can provide a starting point for aparticular jurisdiction label 210 and/or 212 from which modificationscan be made and/or tracked.

A master label 208 (also referred to herein as a Company Core Data Sheet(CCDS) label, but also encompassing main product jurisdiction labelssuch as United States Product Insert (USPI) or European Union Summary ofProduct Characteristics (EUSmPC)) can store basic information about theproduct that can be used to populate a particular downstream mainproduct-jurisdiction label 210 and/or product auxiliary jurisdictionlabel 212. For example, in the pharmaceutical context, a master label208 can include information about the trade name of the product, itsqualitative and/or quantitative composition, medical productinformation, and the like. Such information is likely to be commonacross main product-jurisdiction labels 210 and/or or product auxiliaryjurisdiction labels 212 to be generated. In one embodiment, when theuser has completed adding their information to the CCDS, they can savetheir changes and the CCDS is automatically given a name. The namingconvention in certain embodiments can be specific to the informationalcontent and the state in which the product label is in, such as forexample a version in draft, a version in review, a version pendinginternal approval, a version pending health authority approval (e.g. forlocal label only), or a version pending team review. This automaticnaming convention helps to ensure that the documents are not mislabeledand that the components provided in the naming convention representwhere it is in its workflow and lifecycle. The user can choose to uploadand share the document as public, making it available to other users inthe system, or they can choose to mark it as in-progress and save it asprivate for themselves. This saving and standard naming conventionfunctionality can be performed at any step a save option is available,or whenever the user can create, edit, review and approve a document,including both local labels and the CCDS. In one embodiment, users cansign-off on documents by simply selecting an option to input theirsignature. The signature is populated by automatically pulling from auser profile page. Once all required users approve the document, thedocument will generate an effective date and the document will be lockedas clean with an updated version. The user profile page is unique toindividual users, and the user can update all of their user information,change their user image, upload a new signature, change their passwordor modify their settings from their profile page.

The templates, inclusive of master label template 202 and jurisdictiontemplates 204, 206, prove a framework for each respective label instance208, 210, 212 and enable the structured authoring across label typesaccordingly. For example, sections with similar content across thetemplates 202, 204, 206 can be aligned with each other even thoughsection headers may not be identical across master label template 204and templates 206, 208.

A main jurisdiction template 204 can structure and store basic fieldsand/or information that are required for one or more jurisdictions. Forexample, the U.S. Food and Drug Administration may require differentfields and/or a different format than the European Medicines Agency.

Finally, an auxiliary jurisdiction template 206 can provide specifyfurther information unique to a particular type of label. For example,although a combination label and a patient information label may containidentical or very similar information in a particular jurisdiction, thelabels may be formatted differently.

Information from master label template 202 and templates 204 or 206 canbe combined to generate a particular downstream mainproduct-jurisdiction label 210 and/or product auxiliary jurisdictionlabel 212 as will be further discussed herein.

In one embodiment, a system for generating product label changesincludes a product labeling platform executable on a network enabledcomputing device, and a database of at least one selectable master labeland at least one selectable jurisdiction label associated with a labeledproduct, where the platform associates at least one selected descriptorfrom a first pre-defined descriptor set to each change made to aselected master label, and further associates at least one selecteddescriptor from a second pre-defined descriptor set to each change madeto a selected jurisdiction label, and where the platform furtherassociates a report including the selected descriptors from the firstand second pre-defined descriptor sets with the changed label. In oneembodiment, the first descriptor set includes pre-defined selectableoptions from at least one category from the group consisting of ChangeRationale, Safety Change, and Change Type. In one embodiment, thepre-defined selectable options under the Change Type category include anurgency level. In one embodiment, the pre-defined selectable optionsunder the Change Type category include an identification of mandatory,optional or administrative. In one embodiment, the second descriptor setincludes pre-defined selectable options pertaining to the alignment ofthe information change in the label to the information change in thecompany core data sheet. In one embodiment, the pre-defined selectableoptions are from the group consisting of Major Deviation, MinorDeviation, and Aligned.

Exemplary Method and Infrastructure for Creating and Managing a ProductLabel

Referring now to FIG. 3 , an exemplary method and infrastructure 300 forcreating and managing a product label is depicted.

In step S302, a master label 208 is defined. As depicted in FIG. 4A,user interface 400 can include one or more text entry GUI widgets 402programmed to receive textual (and/or graphic) input and display enteredcontent. User interface 400 can also include one or more formatting GUIwidgets 404 such as buttons that can allow a user to format text (e.g.,as bold, italic, underlined, subscript, superscript, bulleted, numbered,indented, including equations, including photographs, including tablesand the like). Ideally, the user interface 400 can provide a userinterface that is familiar to users of common word processingapplications.

The master label 208 can be populated from a master template 202 (e.g.,provided as part of a software package). The master label 208 caninclude pre-defined section headers that can be tagged, e.g., to allowcorrelation across templates and labels or correlation of content withineach section to the respective section header. The master template 202can be modified within the system by the end user if desired.

In step S304, the master label 208 is saved. The master label 208 can besaved in a variety of formats. In one embodiment, the master label 208is saved in a single file (e.g., plain text .txt file, a Rich TextFormat .rtf file, a HyperText Markup Language .html file, an ExtensibleMarkup Language .xml file, a MICROSOFT® WORD™ .doc or .docx file, aspecified health authority style template (e.g. FDA structured productlabel (SPL), and the like). In other embodiments, the content of themaster label 208 is stored as discrete elements. The discrete elementscan be tagged to a specific label and/or a section within the label aswells as other relevant metadata (e.g., product, therapeutic area,product indication, generic name, brand name, etc.) and can also besearched accordingly. FIG. 4Q depicts one of many ways to search on thediscrete data elements. The discrete data elements can be referenced bya product template data structure and by other data structures. Thediscrete data elements can be also managed and/or tracked and/orreported and/or extracted as single or structured data elements to servea multitude of functions, for example, to meet the requirements ofrequired health authority data structures and governance (e.g.,identification of medicinal products (IDMP)).

In some embodiments, the master label 208 is a structured document. Inone embodiment, one or more tags denote various fields. For example, themaster label 208 can be an XML file that includes the following data:

<tradename>BRAND X ®</tradename> <API>Fluticasone propionate(glucocorticoid) 50 mcg</API> <purpose>Allergy symptomreliever</purpose>In still another embodiment, the master label 208 can be stored as adata structure that contains references to a plurality of elements thatcan be stored separately. Referring again to FIG. 2 , master label 208can include references to elements A-E. Elements can include words,phrases, sentences, paragraphs, images, and the like. When master label208 is accessed (e.g., for viewing, editing, and the like) elements A-Ecan be obtained from local or remote (e.g., cloud-based) disk or memory(e.g., a database 214) and presented as a single document.

In step S306, a user-defined revision and approval workflow can beimplemented. For example, a company can specify that approvals fromparticular individuals are required for any new template, updates to atemplate, a new label, or any changes to a master label 208. Variousworkflow applications, libraries, and other existing techniques can beincorporated within embodiments of the invention. Exemplary workflowdefinition languages include XPDL, YAWL, and SCUFL. Exemplary workflowlibraries and interfaces include Windows Workflow Foundation (WF),Workflow OSID, and Open WFE or can be provided as custom tools withinthe system.

As the master label 208 (and other templates and documents describedherein) is reviewed and/or revised, revisions can be tracked indifferent versions. Version control can be managed through the system byautomatically creating standard naming conventions with associatedversions for each new and/or updated template and/or label in thesystem. For example, embodiments of the invention can implement versioncontrol for master label 208, templates 202, 204, 206, documents, and/orelements that can save and maintain multiple versions and metadataassociated with the same. Revisions can be saved in database 214 andlinked and/or associated with the respective version of the template202, 204, 206 and/or label 208, 210, 212. In one embodiment, the systemissues an automated naming convention to each product label each time itis developed or updated, and the naming convention specifies the statein which the product label is in. The state may include for example aversion in draft, a version in review, a version pending internalapproval, a version pending health authority approval (e.g. for locallabel only), or a version pending team review. In one embodiment, thenaming convention is an additional tag to the product label and the tagsare used for further tracking and reporting of product labels. The usercan choose to make the document available to other users in the system,or they can choose to mark it as in-progress and save it as private forthemselves.

In step S308, a user can select a master label 208 and one or moretemplates for viewing and transfer of data. The user can be presentedwith a variety of user interfaces such as that depicted in FIG. 4B tofacilitate this selection. For example, various options within theProduct, Country, Indication, Brand name, and Label Type categories canbe associated with particular labels and/or templates.

In step S310, corresponding sections of master label 208 and/ortemplates can be presented at the same or substantially the samevertical height and/or position in a user interface as depicted in FIG.4D. This can be implemented using a variety of techniques. For example,in one embodiment, a GUI widget can be programmed to detect a heightand/or position of the beginning of a section in one GUI widget andforce an update to the same position in a second GUI widget, followed bya repaint. For example, tags across labels 202, 204, 206 and/ortemplates 208, 210, 212 can be associated such that even if the text ofa heading differs across templates 202, 204, 206 and/or labels 208, 210,212, corresponding sections will be displayed at the same orsubstantially the same height and/or position within the GUI widgets.

In step S312, data is transferred from a master label 208 or firsttemplate to a second label or template. For example, data from a masterlabel 208 can be transferred to create a main product-jurisdiction label210 for a particular product in a particular jurisdiction or can betransferred to create a product auxiliary jurisdiction label 212.Furthermore, a main product-jurisdiction label 210 can then be combinedwith an auxiliary jurisdiction template 206 as will be discussed hereinto produce a product auxiliary jurisdiction label 212.

Data can be transferred between labels 208, 210, 212 and templates 202,204, 206 in a variety of manners. In one embodiment, associations aredefined with elements or fields of the master label 208 so thatindividual fields (e.g., tradename, API, and the like) in the masterlabel 208 can be mapped directly to an appropriate field defined by thejurisdiction templates 204, 206. In other embodiments and as depicted inFIG. 4D, master label 208 and main product-jurisdiction label 210 can bedisplayed (e.g., side-by-side) in a GUI and the user can select contentfor transfer between labels and/or templates. For example, the user canselect one or more elements for transfer, select particular portions ofan element (e.g., through copying and pasting), drag-and-drop particularelements, elect to transfer all data and then edit, and the like. Oncethe desired data is transferred, the user can then edit the data asneeded.

In step S314, data is edited in the second label 208, 210, 212 ortemplate 202, 204, 206. For example, a user may recognize that aparticular regulatory agency requires certain language that is notrequired in other jurisdictions (and, thus, does not appear in themaster template 202 and/or master label 208). The user can add thislanguage in the second label and/or template. In another example, theuser may recognize that the brand name may differ or require a differenttrademark symbol in a particular country. In the data model depicted inFIG. 2 , this revision can be saved as a new element version andreferenced using that version ID.

In step S314, quality control (QC) can be facilitated through achecklist 406 displayed alongside a label 212 as depicted in FIG. 4E.This feature can also apply to master label 208 and other templates andlabels. The templated QC check-list can be provided as part of asoftware package and can be edited from the tools section of the system.All checklist items that have passed or failed the QC can be tracked andavailable for reporting, so that if the same error repeatedly occurs,the company can address it through training or other action to improvethe quality of deliverables. Similar interfaces can be used forfacilitating QC of master label 208 and labels 210, 212.

In step S314, further approvals of a particular label 212 can beimplemented.

Changes to a label 208, 210, 212 can be tracked using a user interfacesuch as that depicted in FIG. 4F (in the context of changes to apreviously approved local label). Communication of changes and internalreviews can be facilitated through this notification system. GUI widget408 can prompt a user to describe or “qualify” each change to a templateor label by answering a series of questions that can be presented indrop-down, check-box, or other GUI widgets. For example, the user canprovide a summary of changes and specify: a rationale for the change(e.g., new data), whether the change relates to safety, a change type(e.g., “mandatory urgent change”, “mandatory non-urgent change”,“optional change”, “administrative change”, and the like), and whetherthe change represents a major deviation, a minor deviation, or no change(“aligned”) from a source label (e.g., master label 208). (Similarinterfaces can be used for tracking changes to the master label 208, butwill omit the “alignment” information). That data (summary of changesand associated qualifiers) can be linked to the respective label (e.g.,metadata 216 in database 214 and/or other associated database in thesystem and can be aggregated (e.g., for one or more labels and acrossone or more labels) in reports such as those depicted in FIGS. 40 and4P. No existing systems allow companies to automatically track and/orreport changes, especially at a per-change level of granularity andtightly-coupled to the label and, specifically, across labels.

Once the user has completed the summary of changes with the associatedqualifiers, the user can use GUI widget 410 to complete a message thatcan be distributed with the review, QC, and/or approval of a label 208,210, 212. Embodiments of the invention can include “templated” messagesthat can be easily selected from a drop-down list, appear in the messagebox, and be edited before sending. These templated messages can bemodified in a “Tools” or other administrative menu of a software programimplementing embodiments of the invention. These templated messagesadvantageously promote inclusion of critical information that should beincluded in the message.

The user can also specify a deadline for review and a distribution listfor the review request. The distribution lists can be modified “Tools”or other administrative menu of a software program implementingembodiments of the invention. Furthermore, the distribution lists can beimported from other systems (e.g., ACTIVE DIRECTORY®, MICROSOFT EXCHANGESERVER®, OUTLOOK®, and/or SHAREPOINT®, software available from MicrosoftCorporation of Redmond, Washington, a Lightweight Directory AccessProtocol, and the like).

When the user hits the “Send” button, the relevant label and associatedsummary of changes table with all associated qualifiers along with thetemplated (edited) message can be sent to all those on the distributionlist. They will receive the message in their “Deadlines” folder asdepicted in FIG. 4N with the deadline date for review. The receivingparty can note the action taken on the deadline (e.g., completed orwaived) using a user interface (e.g., using GUI widgets 412 as depictedin FIG. 4M). Compliance to the date and action on that deadline can betagged and linked to the respective label (metadata 216), stored indatabase 214 or other associated storage, tracked in the system and canbe aggregated in reports such as those depicted in FIGS. 40 and 4P.

In step S316, compiling components of the label for regulatorysubmission can be facilitated and tracked as depicted in FIGS. 4G-4M.The “H.A. Submission” subpages depicted in FIGS. 4G-4M enable a user toenter additional information (metadata) required for submission of alabel to a health authority (e.g., the U.S. Food and DrugAdministration, the European Medicines Agency, and the like).

For example, the “Labeler Code” tab depicted in FIG. 4G, the“Establishment” tab depicted in FIG. 4H, and the “Drug Listing” tabdepicted in FIG. 4I allows for collection of information required by therelevant health authority and can be tailored to reflect one or moreindividual health authorities. Information entered once in the systemfor another product (and/or relevant label) becomes available to otherusers in a dropdown list so that they can select it for futuresubmissions, thus saving time for repeated re-entry of the sameinformation. This information can be stored in a database 214 asdepicted in FIG. 2 or other data structure. This information can betagged to the respective product and/or label and can be searched,reported, and/or extracted accordingly.

The information entered into the system (and stored in database 214) canbe automatically converted to XML and/or SPL (structured productlabeling) and/or EVMPD (EudraVigilance Medicinal Product Dictionary),which is the format required by many health authorities. This automaticconversion streamlines the process of creating the SPL for submission tothe H.A.

Because all the label and associated metadata can reside in the samedatabase, extracting a label submission package, SPL, EVMPD, and thelike is as efficient as selecting the data required for the submissionand extracting the information in the correct format according. Forexample, FIG. 4J depicts the “SPL Package” tab of the “H.A. Submission”subpages. The user can select the product for which they are compilingthe submission. The user can select whether or not to include the druglisting information. The labeler code information and the establishmentinformation can always be included. The user can select any otherinformation that they want to include in the submission package. Theuser can press the “Compile & Save SPL Package” button to pull thecorrect local label (content as entered previously in the system andformat as specified by the template), the labeler code information, theestablishment code information, the drug listing information (ifselected as required), and compile everything into the SPL format to besubmitted to the H.A. The user can then export the SPL package forsubmission to the H.A. Additionally or alternatively, the system canalso be linked directly to a portal for submission of the SPL package tothe H.A. (e.g., through an application program interface (API)) so thatthe user does not need to leave the system environment for submission.

FIG. 4K depicts the “H.A. Interaction” subpage of the Local Label. Allcorrespondence with the health authorities can be logged (e.g., as adirect entry by the user in the system or as an interface and pull fromalternate systems or databases). The logged information can be storedwithin the database 214 depicted in FIG. 2 and can be associated to therespective product and/or label. The user can filter the informationpulled and displayed on this page by selecting the product and/orcountry and/or label type. Internal approval, H.A. submission, and H.A.approval dates can be stored and displayed for each label. The user canalso add the H.A. correspondence (e.g., using the user interfacedepicted in FIG. 4L) to that label and can view the history of allcorrespondence (e.g., using the user interface depicted in FIG. 4M). Theuser can then generate reports from the database utilizing thisinformation in conjunction with other information within the database214, for example, which local labels required an urgent change and whichcountries submitted those changes and when those changes were submitted.This analysis is currently not possible in any system today and isincredibly challenging without a system that consolidates the data in astructured manner within a single database or repository.

Various steps can be repeated to generate a specific label and/or toiterate through revisions and updates.

As labels and templates are created, various metadata (metadata 216e.g., supporting reference documents) can be generated and saved. Thismetadata can include supporting data such as references supportingvarious statements in a label or template can be associated with thelabel or template and can be automatically compiled for submission forregulatory approval. This metadata can be tagged and linked to therespective label and specifically to the respective statement within thelabel and stored in database 214 or other associated storage, tracked inthe system and can be aggregated and displayed in tables as depicted inFIG. 4T for efficiency. In one embodiment, when viewing a document, theuser can hover over a reference and see what reference was used tocreate the statement, they can then click on that reference and open it.All statements with references can have a special visual indication. Theuser can hover over the statement or visual indication and see whatreference document is attached to that statement and be able to click onit and open the attachment. This provides an advantage over conventionalmethods where many statements in labels go unreferenced because makingthose connections isn't that simple and even when they are referenced,it is hard to find the reference later on. This quick link to thereferences described herein enables a user experience that is much morestreamlined.

Exemplary Method and Infrastructure for Managing an Update to a ProductLabel

Referring now to FIG. 5 , another embodiment of the invention provides amethod and infrastructure 500 for managing an update to a product label.

In step S502, a selection of scope is received. Advantageously, thenested structure of labels 208, 210, 212 and templates 202, 204, 206described herein allows a user to generate changes of varying scope. Forexample, a user may desire to change only a specific label 212, in whichcase the scope will be that particular label 212. In other embodiments,a regulatory authority for a particular jurisdiction may require changesto all labels for a product within a particular jurisdiction, in whichcase the scope can be a particular main jurisdiction template 204. Instill other embodiments, a company may wish to change the format of aparticular type of a particular label, in which case the scope can be anauxiliary jurisdiction template 206. In still other embodiments, acompany may wish to list a new contraindication for a product across alljurisdictions, in which case the scope would be a particular masterlabel 208.

In step S504, a change can be received. For example, the change caninclude modification of text and/or graphics. The change can be madeusing a GUI such as shown in FIG. 4R.

In step S506, a prompt can be presented to the user for informationregarding the change. As depicted in FIG. 4F, the information caninclude one or more of a change rationale, a safety change, a changetype, an urgency level, and the like. For example, the change type caninclude one or more options such as “mandatory”, “optional”,“administrative”, and the like. The change type can also specify adegree of congruence with a source label (e.g., the master label 208) ifthe change is being made to a jurisdiction label 210, 212. For example,a prompt can be presented to the user requesting a selection betweenoptions such as “major deviation”, “minor deviation”, “aligned”, and thelike. These changes are linked to the product label and can be stored indatabase 214, where they can be searched and/or reported on. Suchsearching and reporting is not possible with any other system and allowsseamless reporting (e.g., for compliance purposes) at any given time.

Furthermore, because the content (information) of each label can bestored within the same database 214 or repository and tagged to theassociated label within the defined label structure of the templates202, 204, 206, the data can be extracted the labels 208, 210, 212 can becompared side-by-side with each other as depicted in FIGS. 4D and 4S.Comparisons can toggle between a “word” view and a “table” view,selected based on default or user preference. One benefit of the tableview is that the section sub headers are pulled into their own column,which allows the user to quickly scroll down to the section of interest.Differences in the text can automatically be highlighted so that theuser can quickly identify where the two documents differ. Thehighlighting option may optionally be turned off. The word view givesthe benefit of the user looking at the document in its normal format.

In step S508, the proposed change and associated metadata can becirculated internally for approval as described herein.

In step S510, the proposed change can be provided to the relevant healthauthority for approval as described herein. Appropriate metadatasupporting the proposed change can also be included in the H.A.submission also as described herein.

In step S512, the change can be implemented after internal and H.A.approval.

In another embodiment, a computer-implemented method 600 of updating aproduct label is described. A master label or jurisdiction product labelassociated with a labeled product is selected 602. At least one changeto information contained in a section of the master label orjurisdiction product label is entered 604. The at least one informationchange is qualified via selection of at least one descriptor from afirst pre-defined descriptor set 606. A label is selected for thelabeled product 608. At least one change to information contained in thelabel is entered that is commensurate with the information change in themaster label or jurisdiction product label 610. The at least oneinformation change in the label is qualified via selection of at leastone descriptor from a second pre-defined descriptor set 612. A report ofthe at least one label change is generated including the changed labeland a summary including the selected descriptors from the first andsecond pre-defined descriptor sets 614. In one embodiment, the firstdescriptor set includes pre-defined selectable options from at least onecategory from the group consisting of Change Rationale, Safety Change,and Change Type. In one embodiment, the pre-defined selectable optionsunder the Change Type category include an urgency level. In oneembodiment, the pre-defined selectable options under the Change Typecategory include an identification of mandatory, optional oradministrative. In one embodiment, the second descriptor set includespre-defined selectable options pertaining to the alignment of theinformation change in the label to the information change in the companycore data sheet. In one embodiment, the pre-defined selectable optionsare from the group consisting of Major Deviation, Minor Deviation, andAligned.

Application to Other Regulatory Submissions

Although embodiments of the invention are described in the context ofpharmaceutical labels, embodiments of the system are also applicable toother regulated products such as medical device labels and drug anddevice CMC (Chemistry Manufacturing and Controls) information and/ordocuments as well as general drug and device submissions.

Implementation in Computer-Readable Media and/or Hardware

The methods described herein can be readily implemented in software thatcan be stored in computer-readable media for execution by a computerprocessor, whether locally or remotely (e.g., over a network or “in thecloud”). For example, the computer-readable media can be volatile memory(e.g., random access memory and the like) and/or non-volatile memory(e.g., read-only memory, hard disks, floppy disks, magnetic tape,optical discs, paper tape, punch cards, and the like).

Additionally or alternatively, the methods described herein can beimplemented in computer hardware such as an application-specificintegrated circuit (ASIC).

EQUIVALENTS

Although preferred embodiments of the invention have been describedusing specific terms, such description is for illustrative purposesonly, and it is to be understood that changes and variations may be madewithout departing from the spirit or scope of the following claims.

For example, the functions of several elements can, in alternativeembodiments, be carried out by fewer elements, or a single element.Similarly, in some embodiments, any functional element can performfewer, or different, operations than those described with respect to theillustrated embodiment. Also, functional elements (e.g., modules,databases, computers, clients, servers and the like) shown as distinctfor purposes of illustration can be incorporated within other functionalelements, separated in different hardware or distributed in a particularimplementation.

While certain embodiments according to the invention have beendescribed, the invention is not limited to just the describedembodiments. Various changes and/or modifications can be made to any ofthe described embodiments without departing from the spirit or scope ofthe invention. Also, various combinations of elements, steps, features,and/or aspects of the described embodiments are possible andcontemplated even if such combinations are not expressly identifiedherein.

INCORPORATION BY REFERENCE

The entire contents of all patents, published patent applications, andother references cited herein are hereby expressly incorporated hereinin their entireties by reference.

1-47. (canceled)
 48. A computer-implemented method of updating a productlabel, comprising the steps of: selecting a master label or jurisdictionproduct label associated with a labeled product; entering at least onechange to information contained in a section of the master label orjurisdiction product label; qualifying the at least one informationchange via selection of at least one descriptor from a first pre-defineddescriptor set; selecting a label for the labeled product; entering atleast one change to information contained in the label that iscommensurate with the information change in the master label orjurisdiction product label; qualifying the at least one informationchange in the label via selection of at least one descriptor from asecond pre-defined descriptor set; and generating a report of the atleast one label change comprising the changed label and a summaryincluding the selected descriptors from the first and second pre-defineddescriptor sets.
 49. The computer-implemented method of claim 48,wherein the first descriptor set comprises pre-defined selectableoptions from at least one category from the group consisting of ChangeRationale, Safety Change, and Change Type.
 50. The computer-implementedmethod of claim 49, wherein the pre-defined selectable options under theChange Type category include an urgency level.
 51. Thecomputer-implemented method of claim 49, wherein the pre-definedselectable options under the Change Type category include anidentification of mandatory, optional or administrative.
 52. Thecomputer-implemented method of claim 48, wherein the second descriptorset comprises pre-defined selectable options pertaining to the alignmentof the information change in the label to the information change in themaster label.
 53. The computer-implemented method of claim 52, whereinthe pre-defined selectable options are from the group consisting ofMajor Deviation, Minor Deviation, and Aligned.
 54. A system forgenerating product label changes, comprising: a product labelingplatform executable on a network enabled computing device; and adatabase of at least one selectable master label and at least oneselectable jurisdiction label associated with a labeled product; whereinthe platform associates at least one selected descriptor from a firstpre-defined descriptor set to each change made to a selected masterlabel, and further associates at least one selected descriptor from asecond pre-defined descriptor set to each change made to a selectedjurisdiction label; and wherein the platform further associates a reportincluding the selected descriptors from the first and second pre-defineddescriptor sets with the changed label.
 55. The system of claim 54,wherein the first descriptor set comprises pre-defined selectableoptions from at least one category from the group consisting of ChangeRationale, Safety Change, and Change Type.
 56. The system of claim 55,wherein the pre-defined selectable options under the Change Typecategory include an urgency level.
 57. The system of claim 55, whereinthe pre-defined selectable options under the Change Type categoryinclude an identification of mandatory, optional or administrative. 58.The system of claim 54, wherein the second descriptor set comprisespre-defined selectable options pertaining to the alignment of theinformation change in the label to the information change in the masterlabel.
 59. The system of claim 58, wherein the pre-defined selectableoptions are from the group consisting of Major Deviation, MinorDeviation, and Aligned.
 60. The computer-implemented method of claim 49,wherein the pre-defined selectable options under the Change Rationalecategory include New Data, Health Authority Request, and Update toSource Label.
 61. The system of claim 54, wherein the platform furtherassociates at least one of a Change Rationale or a Safety Change to eachchange made to a selected jurisdiction label.